US FDA code of federal regulations 21 CFR for Dietary Supplements




The 21 CFR is a US-FDA Code of Federal Regulations in which all the food and drug guidlines are enlisted in the subpart wise. Below is the summary of the Dietary guidlines, for more details please write us back.
CONTENTS
US FDA -21CFR & Norms
General Provisions:
  • Manufacturer, the food packaging by another person is liable of 21 CFR (code of federal regulations), the retailers/sellers are not liable to this guideline.
  • Definitions included: Actual Yield, Batch, Batch number/lot number/control number, component, contact surface, ingredient, in-process material, physical plant, product complaint, quality, representative sample, Quality control, quality control personnel, theoretical yield, water activity,
  • The contamination should be avoided at any level all the cGMP, GLP regulations are followed.
Physical plants and grounds
  1. Grounds –clean
  2. Properly storing equipment
  3. Plant facilities
  4. Sanitizing agents
  5. Water supply
  6. Pest control
  7. Control of waste to prevent hazards and contamination
  8. Regular inspection / Sanitation Supervisor
  9. Equipment and utensils
Production And Process Control
  1. Written procedures, BOM, MSDS
  2. Quality Control Checks
  3. Record maintenance
  4. Food additive certification which are not permitted.

21 CFR section 101-Food Labelling 

Subpart A--General Provisions
  1. Principal display panel of package form food.
  2. Information panel of package form food.
  3. Food; name and place of business of manufacturer, packer, or distributor.
  4. Declaration of net quantity of contents.
  5. Nutrient content claims--general principles.
  6. Health claims: general requirements.
  7. Food; prominence of required statements.
  8. Food labeling warning, notice, and safe handling statements.
Subpart B--Specific Food Labeling Requirements
  1. Foods; labeling of spices, flavorings, colorings and chemical preservatives.
  2. Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice.
Subpart C--Specific Nutrition Labeling Requirements and Guidelines
Subpart D--Specific Requirements for Nutrient Content Claims
  1. Nutrient content claims for "good source," "high," "more," and "high potency."
  2. Nutrient content claims for "light" or "lite."
  3. Nutrient content claims for the calorie content of foods.
  4. Nutrient content claims for the sodium content of foods.
  5. Nutrient content claims for fat, fatty acid, and cholesterol content of foods.
  6. Implied nutrient content claims and related label statements.
  7. Petitions for nutrient content claims.
Subpart E--Specific Requirements for Health Claims
Petitions for health claims.
  • Health claims: claims not authorized.
  • Health claims: calcium, vitamin D, and osteoporosis.
  • Health claims: dietary lipids and cancer.
  • Health claims: sodium and hypertension.
  • Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease.
  • Health claims: fiber-containing grain products, fruits, and vegetables and cancer.
  • Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease.
  • Health claims: fruits and vegetables and cancer.
  • Health claims: Folate and neural tube defects.
  • Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries.
  • Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD).
  • Health claims: Soy protein and risk of coronary heart disease (CHD).
  • Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD).
Subpart F--Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims
Gluten-free labeling of food.
Certain types of statements for dietary supplements.
"Fresh," "freshly frozen," "fresh frozen," "frozen fresh."
Subpart G--Exemptions From Food Labeling Requirements
Food; exemptions from labeling.
Temporary exemptions for purposes of conducting authorized food labeling experiments.

21 CFR section 104-Nutritional Quality Guidelines

Subpart A--General Provisions
A nutritional quality guideline prescribes the minimum level or range of nutrient composition (nutritional quality) appropriate for a given class of food.
Labeling for a product which complies with all of the requirements of the nutritional quality guideline established for its class of food may state "This product provides nutrients in amounts appropriate for this class of food as determined by the U.S. Government," except that the words "this product" are optional. This statement, if used, shall be printed on the principal display panel, and may also be printed on the information panel, in letters not larger than twice the size of the minimum type required for the declaration of net quantity of contents by 101.7 of this chapter. Labeling of noncomplying products may not include any such statement or otherwise represent, suggest, or imply the product as being, in whole or in part, in compliance with a guideline.
A product bearing the statement provided for in paragraph (b) of this section, in addition to meeting the requirements of the applicable nutritional quality guideline, shall comply with the following requirements:
No claim or statement may be made on the label or in labeling representing, suggesting, or implying any nutritional or other differences between a product to which nutrient addition has or has not been made in order to meet the guideline, except that a nutrient addition shall be declared in the ingredient statement.
 Compliance with a nutrient level specified in a nutritional quality guideline shall be determined by the procedures and requirements established in 101.9(g) of this chapter.
A product within a class of food for which a nutritional quality guideline has been established and to which has been added a discrete nutrient either for which no minimum nutrient level or nutrient range or other allowance has been established as appropriate in the nutritional quality guideline, or at a level that exceeds any maximum established as appropriate in the guideline, shall be ineligible to bear the guideline statement provided for in paragraph (b) of this section, and such a product shall also be deemed to be misbranded under the act unless the label and all labeling bear the following prominent and conspicuous statement: "The addition of ___ to (or "The addition of ___ at the level contained in) this product has been determined by the U.S. Government to be unnecessary and inappropriate and does not increase the dietary value of the food," the blank to be filled in with the common or usual name of the nutrient(s) involved.
Subpart B--Fortification Policy
The fundamental objective of this subpart is to establish a uniform set of principles that will serve as a model for the rational addition of nutrients to foods. The achievement and maintenance of a desirable level of nutritional quality in the nation's food supply is an important public health objective. The addition of nutrients to specific foods can be an effective way of maintaining and improving the overall nutritional quality of the food supply. However, random fortification of foods could result in over- or underfortification in consumer diets and create nutrient imbalances in the food supply. It could also result in deceptive or misleading claims for certain foods. The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages. To preserve a balance of nutrients in the diet, manufacturers who elect to fortify foods are urged to utilize these principles when adding nutrients to food. It is reasonable to anticipate that the Reference Daily Intakes (RDI's) as delineated in 101.9 of this chapter and in paragraph (d) of this section will be amended from time to time to list additional nutrients and/or to change the levels of specific RDI's as improved knowledge about human nutrient requirements and allowances develops. The policy set forth in this section is based on U.S. dietary practices and nutritional needs and may not be applicable in other countries.
 A nutrient(s) listed in paragraph (d)(3) of this section may appropriately be added to a food to correct a dietary insufficiency recognized by the scientific community to exist and known to result in nutritional deficiency disease if:
(1) Sufficient information is available to identify the nutritional problem and the affected population groups, and the food is suitable to act as a vehicle for the added nutrients. Manufacturers contemplating using this principle are urged to contact the Food and Drug Administration before implementing a fortification plan based on this principle.
(2) The food is not the subject of any other Federal regulation for a food or class of food that requires, permits, or prohibits nutrient additions. (Other Federal regulations include, but are not limited to, standards of identity promulgated under section 401 of the Federal Food, Drug, and Cosmetic Act, nutritional quality guidelines established in subpart C of this part, and common or usual name regulations established in part 102 of this chapter.)
A nutrient(s) listed in paragraph (d)(3) of this section may appropriately be added to a food to restore such nutrient(s) to a level(s) representative of the food prior to storage, handling, and processing, when:
(1) The nutrient is shown by adequate scientific documentation to have been lost in storage, handling, or processing in a measurable amount equal to at least 2 percent of the Daily Reference Value (DRV) of protein and of potassium and 2 percent of the Reference Daily Intake (RDI) in a normal serving of the food.
(2) Good manufacturing practices and normal storage and handling procedures cannot prevent the loss of such nutrient(s),
(3) All nutrients, including protein, iodine and vitamin D, that are lost in a measurable amount are restored and all ingredients of the food product that contribute nutrients are considered in determining restoration levels; and
(4) The food is not the subject of any other Federal regulation that requires or prohibits nutrient addition(s), or the food has not been fortified in accordance with any other Federal regulation that permits voluntary nutrient additions.
 A nutrient(s) listed in paragraph (d)(3) of this section may be added to a food in proportion to the total caloric content of the food, to balance the vitamin, mineral, and protein content if:
(1) A normal serving of the food contains at least 40 kilocalories (that is, 2 percent of a daily intake of 2,000 kilocalories);
(2) The food is not the subject of any other Federal regulation for a food or class of food that requires, permits, or prohibits nutrient additions; and
(3) The food contains all of the following nutrients per 100 calories based on 2,000 calorie total intake as a daily standard:

Nutrient

Unit of measurement

DRV or RDI 1

Amount per 100 calories

Protein

grams (g)

50

2.5

Vitamin A

International Unit (IU)

5,000

250

Vitamin C

milligrams (mg)

60

3

Calcium

G

1

0.05

Iron

Mg

18

0.9

Vitamin D

IU

400

20

Vitamin E

Do

30

1.5

Thiamin

Mg

1.5

0.08

Riboflavin

Do

1.7

0.09

Niacin

Do

20

1

Vitamin B6

Do

2.0

0.1

Folate

micrograms ([micro]g)

400

20

Vitamin B12

Do

6.0

0.3

Biotin

Mg

0.3

0.015

Pantothenic acid

Do

10

0.5

Phosphorus

G

1.0

0.05

Magnesium

Mg

400

20

Zinc

Do

15

0.8

Iodine

[micro]g

150

7.5

Copper

Mg

2.0

0.1

Potassium

Do

3,500

175
1RDI's for adults and children 4 or more years of age.
A nutrient(s) may appropriately be added to a food that replaces traditional food in the diet to avoid nutritional inferiority in accordance with 101.3(e)(2) of this chapter.
Nutrient(s) may be added to foods as permitted or required by applicable regulations established elsewhere in this chapter.
A nutrient added to a food is appropriate only when the nutrient:
(1) Is stable in the food under customary conditions of storage, distribution, and use;
(2) Is physiologically available from the food;
(3) Is present at a level at which there is a reasonable assurance that consumption of the food containing the added nutrient will not result in an excessive intake of the nutrient, considering cumulative amounts from other sources in the diet; and
(4) Is suitable for its intended purpose and is in compliance with applicable provisions of the act and regulations governing the safety of substances in food.



Any claims or statements in the labeling of food about the addition of a vitamin, mineral, or protein to a food shall be made only if the claim or statement is not false or misleading and otherwise complies with the act and any applicable regulations. The following label claims are acceptable:
(1) The labeling claim "fully restored with vitamins and minerals" or "fully restored with vitamins and minerals to the level of unprocessed ___" (the blank to be filled in with the common or usual name of the food) may be used to describe foods fortified in accordance with the principles established in paragraph (c) of the section.
(2) The labeling claim, "vitamins and minerals (and "protein" when appropriate) added are in proportion to caloric content" may be used to describe food fortified in accordance with the principles established in paragraph (d) of this section.
(3) When labeling claims are permitted, the term "enriched," "fortified," "added," or similar terms may be used interchangeably to indicate the addition of one or more vitamins or minerals or protein to a food, unless an applicable Federal regulation requires the use of specific words or statements.
It is inappropriate to make any claim or statement on a label or in labeling, other than in a listing of the nutrient ingredients as part of the ingredient statement, that any vitamin, mineral, or protein has been added to a food to which nutrients have been added pursuant to paragraph (e) of this section.

21 CFR section 105-Food For special dietary use

Subpart A--General Provisions
The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act (hereafter "the act") shall be applicable with the following additions:
The term special dietary uses, as applied to food for man, means particular (as distinguished from general) uses of food, as follows:
(i) Uses for supplying particular dietary needs which exist by reason of a physical, physiological, pathological or other condition, including but not limited to the conditions of diseases, convalescence, pregnancy, lactation, allergic hypersensitivity to food, underweight, and overweight;
(ii) Uses for supplying particular dietary needs which exist by reason of age, including but not limited to the ages of infancy and childhood;
(iii) Uses for supplementing or fortifying the ordinary or usual diet with any vitamin, mineral, or other dietary property. Any such particular use of a food is a special dietary use, regardless of whether such food also purports to be or is represented for general use.
The use of an artificial sweetener in a food, except when specifically and solely used for achieving a physical characteristic in the food which cannot be achieved with sugar or other nutritive sweetener, shall be considered a use for regulation of the intake of calories and available carbohydrate, or for use in the diets of diabetics and is therefore a special dietary use.
c) For the purposes of the regulations in this part, the terms infant, child, and adult mean persons not more than 12 months old, more than 12 months but less than 12 years old, and 12 years or more old, respectively.
Subpart B--Label Statements

Sec. 105.62 Hypoallergenic foods.

If a food purports to be or is represented for special dietary use by reason of the decrease or absence of any allergenic property or by reason of being offered as food suitable as a substitute for another food having an allergenic property, the label shall bear:
The common or usual name and the quantity or proportion of each ingredient (including spices, flavoring, and coloring) in case the food is fabricated from two or more ingredients.
A qualification of the name of the food, or the name of each ingredient thereof in case the food is fabricated from two or more ingredients, to reveal clearly the specific plant or animal that is the source of such food or of such ingredient, if such food or such ingredient consists in whole or in part of plant or animal matter and such name does not reveal clearly the specific plant or animal that is such a source.
 An informative statement of the nature and effect of any treatment or processing of the food or any ingredient thereof, if the changed allergenic property results from such treatment or processing.

Sec. 105.65 Infant foods.

If a food (other than a dietary supplement of vitamins and/or minerals alone) purports to be or is represented for special dietary use for infants, the label shall bear, if such food is fabricated from two or more ingredients, the common or usual name of each ingredient, including spices, flavoring, and coloring.
If such food, or any ingredient thereof, consists in whole or in part of plant or animal matter and the name of such food or ingredient does not clearly reveal the specific plant or animal which is its source, such name shall be so qualified as to reveal clearly the specific plant or animal that is such source.

Sec. 105.66 Label statements relating to usefulness in reducing or maintaining body weight.

General requirements. Any food that purports to be or is represented for special dietary use because of usefulness in reducing or maintaining body weight shall bear:
Nutrition labeling in conformity with 101.9, or, where applicable, 101.36 of this chapter, unless exempt under that section; and
A conspicuous statement of the basis upon which the food claims to be of special dietary usefulness.
Non-nutritive ingredients.
 Any food subject to paragraph (a) of this section that achieves its special dietary usefulness by use of a nonnutritive ingredient (i.e., one not utilized in normal metabolism) shall bear on its label a statement that it contains a nonnutritive ingredient and the percentage by weight of the nonnutritive ingredient.
A special dietary food may contain a nonnutritive sweetener or other ingredient only if the ingredient is safe for use in the food under the applicable law and regulations of this chapter. Any food that achieves its special dietary usefulness in reducing or maintaining body weight through the use of a nonnutritive sweetener shall bear on its label the statement required by paragraph (b)(1) of this section, but need not state the percentage by weight of the nonnutritive sweetener. If a nutritive sweetener(s) as well as nonnutritive sweetener(s) is added, the statement shall indicate the presence of both types of sweetener, e.g., "Sweetened with nutritive sweetener(s) and nonnutritive sweetener(s)."
 "Low calorie" foods. A food purporting to be "low calorie" must comply with the criteria set forth for such foods in 101.60(b)(2) and (b)(3) of this chapter.
 "Reduced calorie" foods and other comparative calorie claims. A food purporting to be "reduced calorie" or otherwise containing fewer calories than a reference food must comply with the criteria set forth for such food in 101.60(b)(4) and (b)(5) of this chapter.
 Label terms suggesting usefulness as low calorie or reduced calorie foods.
Except as provided in paragraphs (e)(2) and (e)(3) of this section, and in 101.13(q)(2) of this chapter for soft drinks, a food may be labeled with terms such as "diet," "dietetic," "artificially sweetened," or "sweetened with nonnutritive sweetener" only if the claim is not false and misleading, and the food is labeled "low calorie" or "reduced calorie" or bears another comparative calorie claim in compliance with part 101 of this chapter and this section.
Paragraph (e)(1) of this section shall not apply to any use of such terms that is specifically authorized by regulation governing a particular food, or, unless otherwise restricted by regulation, to any use of the term "diet" that clearly shows that the food is offered solely for a dietary use other than regulating body weight, e.g., "for low-sodium diets."
Paragraph (e)(1) of this section shall not apply to any use of such terms on a formulated meal replacement or other food that is represented to be of special dietary use as a whole meal, pending the issuance of a regulation governing the use of such terms on foods.
 "Sugar free," and "no added sugar." Criteria for the use of the terms "sugar free" and "no added sugar" are provided for in 101.60(c) of this chapter.

21 CFR section 110-111-cGMP, Manufacturing & Packaging

Subpart A--General Provisions
110.3 - Definitions.
110.5 - Current good manufacturing practice.
110.10 - Personnel.
110.19 - Exclusions.
Subpart B--Buildings and Facilities
110.20 - Plant and grounds.
110.35 - Sanitary operations.
110.37 - Sanitary facilities and controls.
Subpart C--Equipment
110.40 - Equipment and utensils.
Subpart D [Reserved]
Subpart E--Production and Process Controls
110.80 - Processes and controls.
110.93 - Warehousing and distribution.
Subpart F [Reserved]
Subpart G--Defect Action Levels
110.110 - Natural or unavoidable defects in food for human use that present no health hazard.
[Production Process control and Quality control, Record Keeping]

21 CFR section 190-Dietary Supplement

Subpart B--New Dietary Ingredient Notification
Sec. 190.6 Requirement for premarket notification.
At least 75 days before introducing or delivering for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered, the manufacturer or distributor of that supplement, or of the new dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, information including any citation to published articles that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe. An original and two copies of this notification shall be submitted.
The notification required by paragraph (a) of this section shall include:
The name and complete address of the manufacturer or distributor of the dietary supplement that contains a new dietary ingredient, or of the new dietary ingredient;
The name of the new dietary ingredient that is the subject of the premarket notification, including the Latin binomial name (including the author) of any herb or other botanical;
 A description of the dietary supplement or dietary supplements that contain the new dietary ingredient including:
The level of the new dietary ingredient in the dietary supplement; and
The conditions of use recommended or suggested in the labeling of the dietary supplement, or if no conditions of use are recommended or suggested in the labeling of the dietary supplement, the ordinary conditions of use of the supplement;
The history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe, including any citation to published articles or other evidence that is the basis on which the distributor or manufacturer of the dietary supplement that contains the new dietary ingredient has concluded that the new dietary supplement will reasonably be expected to be safe. Any reference to published information offered in support of the notification shall be accompanied by reprints or photostatic copies of such references. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation; and
he signature of the person designated by the manufacturer or distributor of the dietary supplement that contains a new dietary ingredient.
FDA will acknowledge its receipt of a notification made under section 413 of the Federal Food, Drug, and Cosmetic Act (the act) and will notify the submitter of the date of receipt of such a notification. The date that the agency receives the notification submitted under paragraph (a) of this section is the filing date for the notification. For 75 days after the filing date, the manufacturer or distributor of a dietary supplement that contains a new dietary ingredient shall not introduce, or deliver for introduction, into interstate commerce the dietary supplement that contains the new dietary ingredient.
If the manufacturer or distributor of a dietary supplement that contains a new dietary ingredient, or of the new dietary ingredient, provides additional information in support of the new dietary ingredient notification, the agency will review all submissions pertaining to that notification, including responses made to inquiries from the agency, to determine whether they are substantive and whether they require that the 75-day period be reset. If the agency determines that the new submission is a substantive amendment, FDA will assign a new filing date. FDA will acknowledge receipt of the additional information and, when applicable, notify the manufacturer of the new filing date, which is the date of receipt by FDA of the information that constitutes the substantive amendment.
FDA will not disclose the existence of, or the information contained in, the new dietary ingredient notification for 90 days after the filing date of the notification. After the 90th day, all information in the notification will be placed on public display, except for any information that is trade secret or otherwise confidential commercial information.
Failure of the agency to respond to a notification does not constitute a finding by the agency that the new dietary ingredient or the dietary supplement that contains the new dietary ingredient is safe or is not adulterated under section 402 of the act.

21 CFR section 200-General

Subpart A--General Provisions
200.5 - Mailing of important information about drugs.
200.7 - Supplying pharmacists with indications and dosage information.
200.10 - Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers.
200.11 - Use of octadecylamine in steam lines of drug establishments.
200.15 - Definition of term "insulin."
Subpart B [Reserved]
Subpart C--Requirements for Specific Classes of Drugs
200.50 - Ophthalmic preparations and dispensers.
200.51 - Aqueous-based drug products for oral inhalation.
Subpart D [Reserved]
Subpart E--Prescription Drug Consumer Price Listing
200.200 - Prescription drugs; reminder advertisements and reminder labeling to provide price information to consumers.

21 CFR section 201-Labelling

Subpart A--General Labeling Provisions
201.1 - Drugs; name and place of business of manufacturer, packer, or distributor.
201.2 - Drugs and devices; National Drug Code numbers.
201.5 - Drugs; adequate directions for use.
201.6 - Drugs; misleading statements.
201.10 - Drugs; statement of ingredients.
201.15 - Drugs; prominence of required label statements.
201.16 - Drugs; Spanish-language version of certain required statements.
201.17 - Drugs; location of expiration date.
201.18 - Drugs; significance of control numbers.
201.19 - Drugs; use of term "infant".
201.20 - Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
201.21 - Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
201.22 - Prescription drugs containing sulfites; required warning statements.
201.23 - Required pediatric studies.
201.24 - Labeling for systemic antibacterial drug products.
201.25 - Bar code label requirements.
201.26 - Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.
Subpart B--Labeling Requirements for Prescription Drugs and/or Insulin
201.50 - Statement of identity.
201.51 - Declaration of net quantity of contents.
201.55 - Statement of dosage.
201.56 - Requirements on content and format of labeling for human prescription drug and biological products.
201.57 - Specific requirements on content and format of labeling for human prescription drug and biological products described in 201.56(b)(1).
201.58 - Waiver of labeling requirements.
Subpart C--Labeling Requirements for Over-the-Counter Drugs
201.60 - Principal display panel.
201.61 - Statement of identity.
201.62 - Declaration of net quantity of contents.
201.63 - Pregnancy/breast-feeding warning.
201.64 - Sodium labeling.
201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.
201.70 - Calcium labeling.
201.71 - Magnesium labeling.
201.72 - Potassium labeling.
201.80 - Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in 201.56(b)(1).
Subpart D--Exemptions From Adequate Directions for Use
201.100 - Prescription drugs for human use.
201.105 - Veterinary drugs.
201.115 - New drugs or new animal drugs.
201.116 - Drugs having commonly known directions.
201.117 - Inactive ingredients.
201.119 - In vitro diagnostic products.
201.120 - Prescription chemicals and other prescription components.
201.122 - Drugs for processing, repacking, or manufacturing.
201.125 - Drugs for use in teaching, law enforcement, research, and analysis.
201.127 - Drugs; expiration of exemptions.
201.128 - Meaning of "intended uses".
201.129 - Drugs; exemption for radioactive drugs for research use.
Subpart E--Other Exemptions
201.150 - Drugs; processing, labeling, or repacking.
201.161 - Medical gases.
Subpart F--Labeling Claims for Drugs in Drug Efficacy Study
201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.
Subpart G--Specific Labeling Requirements for Specific Drug Products
201.300 - Notice to manufacturers, packers, and distributors of glandular preparations.
201.301 - Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
201.302 - Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
201.303 - Labeling of drug preparations containing significant proportions of wintergreen oil.
201.304 - Tannic acid and barium enema preparations.
201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
201.306 - Potassium salt preparations intended for oral ingestion by man.
201.307 - Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale.
201.309 - Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
201.310 - Phenindione; labeling of drug preparations intended for use by man.
201.311 - [Reserved]
201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.
201.313 - Estradiol labeling.
201.314 - Labeling of drug preparations containing salicylates.
201.315 - Over-the-counter drugs for minor sore throats; suggested warning.
201.316 - Drugs with thyroid hormone activity for human use; required warning.
201.317 - Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
201.319 - Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophiltragacanth, and xanthan gum) as active ingredients; required warnings and directions.
201.320 - Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
201.323 - Aluminum in large and small volume parenterals used in total parenteral nutrition.
201.325 - Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.
201.326 - Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.
201.327 - Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.
201.328 - Labeling of medical gas containers.
Source and Credit-US FDA

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